ObesityNCT04412954
Improving Cardiovascular Risk Factors in Black Young Adults
A study testing Smartphone + Text Messaging with Health Coach in people with Obesity, run by Ohio State University at 1 site in United States.
Trial summary
The objectives of the study are to conduct a randomized controlled trial to test the efficacy of the Smartphone intervention on % weight loss and maintaining % weight loss at 6 and 12 months in a sample (N=256) of Black community college students who are overweight or obese, ages 18-25 years. Read more about this study
- Who is it for?
- Ages 17 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Smartphone + Text Messaging with Health Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2020to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age 17-25 years
- Current CSCC student
- Identify as Black
- BMI ≥ 25
- Speaks and reads English
- Interested in losing weight through diet and physical activity changes
- Owns a smartphone or iPhone Operating System (iOS) or Android compatible device
- Ability to return for 12-month visit
Who cannot join
- currently pregnant or planning to become pregnant in next 12 months
- Currently participating in another structured weight loss program or taking weight loss medications or medication known to increase weight
- Lost 10% or more of body weight in past 6 months
- Screens positive for disordered eating symptoms
- diagnosed with type I diabetes
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of the study are to conduct a randomized controlled trial to test the efficacy of the Smartphone intervention on % weight loss and maintaining % weight loss at 6 and 12 months in a sample (N=256) of Black community college students who are overweight or obese, ages 18-25 years. Investigators will also examine mediating variables of the intervention on weight at 6 and 12 months, including adherence to self-monitoring, discrimination, and dietary and physical activity self-efficacy. In addition, investigators will explore potential moderators of weight loss at 6 months and 12 months, including depressive symptoms, ideal body image, and motivation.
Read the detailed description
A total of 256 students, ages 18-25, who meet the inclusion and exclusion criteria will be recruited from Columbus State Community College (CSCC). A sample size of 256 subjects (n=128 per each trial arm) will have sufficient power (>80%) to detect an average between-group difference with a moderate effect size of 0.4. The mixed effect modeling for repeated outcome measures at 6 and 12 months was used for the power calculation using two-sided significance level of 0.05 assuming 1) first-order autoregressive covariance structure, 2) the within-structure correlation of 0.8, and 3) 20% attrition rate at 12-month follow-up. The effect size of 0.4 was reasonably assumed based on data from published trials on weight-loss interventions (an effect size of 0.8 using 8-week social media, 0.3 using 12-week Smartphone intervention, and 0.6 using 4-month text messaging). Investigators will conduct stratified recruitment by gender (female vs. male) and ethnicity (Non-Hispanic Black vs. Hispanic Black) to achieve a study sample with 80% Non-Hispanic Black and 20% Hispanic and 50% male in each ethnic group. The recruitment and randomization will be equally distributed with approximately 10 subjects per month, which is a feasible enrollment target considering the pool of eligible participants and our previous recruitment success.
Prospective participants who contact through telephone or email will undergo a preliminary screening via telephone and receive an explanation of the study. Included in this screening are four questions from the Eating Attitude Test-26 (EAT-26), which will be asked to determine symptoms of disordered eating in the past 6 months. Those who seem to meet eligibility criteria and are interested in participating will be scheduled for an in person visit for the informed consent and screening process.
Following the informed consent process and baseline visit questionnaires, participants will be randomly assigned to intervention or the attention-control group. Investigators will use stratified randomization by sex (female vs. male) and ethnicity (Non-Hispanic Black vs. Hispanic Black). For each gender strata, randomization will occur in permuted blocks of varying block sizes. Subjects in each block will be randomly assigned to intervention arm or attention-control arm with an allocation ratio of 1:1. The advantage of permuted block randomization is that it will ensure balance in the number of subjects in the two trial arms during the entire study period.
- Conditions
- Obesity
- Being tested
- Smartphone + Text Messaging with Health Coach
- Keywords
- minority, College Student, Nutrition, Physical Activity, Health Coach
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone + Text Messaging with Health CoachBehavioural
The program includes (1) use of a free commercially available smartphone application program for 12 months, (2) a wearable Fitbit Charge device that will be provided by the study to monitor active minutes, and (3) one 45-minute behavioral counseling session focused on healthy eating and exercise and (4) personalized text messaging for 6 months by a health coach. The health coach will not send feedback during months 6-12. The intervention will be fully self-directed in these months, as there will be no contact between the 6 months visit and 12-month visit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Health coach with Smartphone application for diet and physical activity Receives: Behavioral: Smartphone + Text Messaging with Health Coach |
| Control | No intervention | No intervention, using a Smartphone application for sleep monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Body weight will be measured in light clothing without shoes using the Tanita Body Scale (BS)
Measured: Baseline to 12 months
Physical Activity-Active Minutes/Day
Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average active minutes per day will be used as measurement. This data represents active minutes per day at 12 months
Measured: 12 months
Physical Activity-Steps/Day
Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average steps taken per day will be used as measurement.
Measured: 12 months
Food Frequency Questionnaire (FFQ)
The full-length block FFQ will be used to assess diet for 7 days at each period of data collection. This is not a scale, this is a measure of foods consumed over a period of 7 days. We measured and target sodium as the nutrient of choice to analyze
Measured: 12 months
Healthy Eating Index (HEI)
A healthy eating index score will be calculated at each time period from the FFQ. The scale ranges from 0-100 with 100 being the best possible score indicating healthy diet aligning with key dietary recommendations.
Measured: 12 months
Secondary outcomes (8)
Rate of Participants Who Are Adherent to Self-Monitoring
Intervention condition only. Adherence will be defined as those participants who enter at least 50% of their caloric goal on at least 80% of days (or 24 days per months).
Measured: Baseline to 12 months
Dietary Self-Efficacy Scale (Diet-SE)
14 questions that examine the participant's belief in their ability to cut down on high caloric foods. Scale ranges from 0-4 with 0 being "not at all confident" and 4 being "very confident" Higher overall score indicates higher levels of self confidence. Total score ranges from 0-56. Total score is reported.
Measured: 12 months
Self-Efficacy for Exercise Scale
9 questions that examine the participant's belief in their ability to complete physical activity in given circumstances. Scale ranges from 0-10 with 0 being not at all confident and 10 being the most confident. Overall scores range from 0-90 with 90 indicating high confidence levels for exercise.
Measured: 12 months
Experiences of Discrimination Scale (EoD)
Examines perceived experiences of discrimination in given circumstances, such as work, public settings, banks, schools, medical care. 17 questions total. Scale ranges from never to four or more times. Four or more times being selected indicates higher levels of discrimination experiences. Total score reported. Higher score means higher levels of discrimination. Total score can range from 0 - 68
Measured: 12 months
Patient Health Questionnaire (PHQ) for Adults, PHQ-9
Measures depressive symptoms using the patient health questionnaire for adults. Questions are scored from 0-3, with lower scores indicating no/lower depressive symptoms. Total score can range from 0-27
Measured: 12 months
Ideal Body Image
Measures patient perception of their current body image and their ideal body. image using a graphic scale ranging from 0-9, with 9 indicating higher levels of overweight/obesity.
Measured: 12 months
Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise
30 questions to measure motivation to lose weight by examining three types of motivation. Scale ranges from 0-7 with 0 being "not at all" and 7 being "very true". A higher score indicates higher levels of motivation for diet and exercise habits. Total score can range from 0 - 210
Measured: 12 months
NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support
16 questions to measure perceived levels of emotional support. Scale ranges from 1-5 with 1 being "never" and 5 being "always. A higher level score indicates higher level of emotional support. Total scores can range from 16-80
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start5 Dec 2020
- Primary completion1 Jan 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janna Stephens, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412954
- Sponsor's protocol ID
- 2019B0560
- Status last verified
- Apr 2025
- First submitted
- 18 May 2020
- Last updated
- 16 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stephens J, Randolph J, Burke L, Miller C, Tan A, Buffington B, Melnyk B, Perkins A. A randomized controlled trial for reduction of risk factors for cardiovascular disease in young adults: Methods of the Aspire study. Contemp Clin Trials. 2022 Oct;121:106873. doi: 10.1016/j.cct.2022.106873. Epub 2022 Sep 5.
PubMed 36070664Leissa SM, Randolph JC, Stephens JD. Recruitment of Black Identifying Young Adults into Clinical Trials: a Report from the Field. J Urban Health. 2021 Oct;98(Suppl 2):155-159. doi: 10.1007/s11524-021-00569-4. Epub 2021 Aug 13. No abstract available.
PubMed 34389927
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cardiovascular Risk Factors in Black Young Adults
- ClinicalTrials.gov ID
- NCT04412954
- Acronym / sponsor ID
- 2019B0560
- Conditions
- Obesity
- Keywords
- minority, College Student, Nutrition, Physical Activity, Health Coach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 5 Dec 2020 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Posted 16 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the study are to conduct a randomized controlled trial to test the efficacy of the Smartphone intervention on % weight loss and maintaining % weight loss at 6 and 12 months in a sample (N=256) of Black community college students who are overweight or obese, ages 18-25 years. Investigators will also examine mediating variables of the intervention on weight at 6 and 12 months, including adherence to self-monitoring, discrimination, and dietary and physical activity self-efficacy. In addition, investigators will explore potential moderators of weight loss at 6 months and 12 months, including depressive symptoms, ideal body image, and motivation.
Detailed description
A total of 256 students, ages 18-25, who meet the inclusion and exclusion criteria will be recruited from Columbus State Community College (CSCC). A sample size of 256 subjects (n=128 per each trial arm) will have sufficient power (>80%) to detect an average between-group difference with a moderate effect size of 0.4. The mixed effect modeling for repeated outcome measures at 6 and 12 months was used for the power calculation using two-sided significance level of 0.05 assuming 1) first-order autoregressive covariance structure, 2) the within-structure correlation of 0.8, and 3) 20% attrition rate at 12-month follow-up. The effect size of 0.4 was reasonably assumed based on data from published trials on weight-loss interventions (an effect size of 0.8 using 8-week social media, 0.3 using 12-week Smartphone intervention, and 0.6 using 4-month text messaging). Investigators will conduct stratified recruitment by gender (female vs. male) and ethnicity (Non-Hispanic Black vs. Hispanic Black) to achieve a study sample with 80% Non-Hispanic Black and 20% Hispanic and 50% male in each ethnic group. The recruitment and randomization will be equally distributed with approximately 10 subjects per month, which is a feasible enrollment target considering the pool of eligible participants and our previous recruitment success.
Prospective participants who contact through telephone or email will undergo a preliminary screening via telephone and receive an explanation of the study. Included in this screening are four questions from the Eating Attitude Test-26 (EAT-26), which will be asked to determine symptoms of disordered eating in the past 6 months. Those who seem to meet eligibility criteria and are interested in participating will be scheduled for an in person visit for the informed consent and screening process.
Following the informed consent process and baseline visit questionnaires, participants will be randomly assigned to intervention or the attention-control group. Investigators will use stratified randomization by sex (female vs. male) and ethnicity (Non-Hispanic Black vs. Hispanic Black). For each gender strata, randomization will occur in permuted blocks of varying block sizes. Subjects in each block will be randomly assigned to intervention arm or attention-control arm with an allocation ratio of 1:1. The advantage of permuted block randomization is that it will ensure balance in the number of subjects in the two trial arms during the entire study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Smartphone + Text Messaging with Health CoachHealth coach with Smartphone application for diet and physical activity |
| Control | No intervention | –No intervention, using a Smartphone application for sleep monitoring |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- age 17-25 years
- Current CSCC student
- Identify as Black
- BMI ≥ 25
- Speaks and reads English
Key exclusion criteria (5 listed)
- currently pregnant or planning to become pregnant in next 12 months
- Currently participating in another structured weight loss program or taking weight loss medications or medication known to increase weight
- Lost 10% or more of body weight in past 6 months
- Screens positive for disordered eating symptoms
- diagnosed with type I diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone + Text Messaging with Health CoachThe program includes (1) use of a free commercially available smartphone application program for 12 months, (2) a wearable Fitbit Charge device that will be provided by the study to monitor active minutes, and (3) one 45-minute behavioral counseling session focused on healthy eating and exercise and (4) personalized text messaging for 6 months by a health coach. The health coach will not send feedback during months 6-12. The intervention will be fully self-directed in these months, as there will be no contact between the 6 months visit and 12-month visit. | Behavioural | Intervention |
Primary outcome
Change in Body Weight
Time frame: Baseline to 12 months
Body weight will be measured in light clothing without shoes using the Tanita Body Scale (BS)
Physical Activity-Active Minutes/Day
Time frame: 12 months
Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average active minutes per day will be used as measurement. This data represents active minutes per day at 12 months
Physical Activity-Steps/Day
Time frame: 12 months
Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average steps taken per day will be used as measurement.
Food Frequency Questionnaire (FFQ)
Time frame: 12 months
The full-length block FFQ will be used to assess diet for 7 days at each period of data collection. This is not a scale, this is a measure of foods consumed over a period of 7 days. We measured and target sodium as the nutrient of choice to analyze
Healthy Eating Index (HEI)
Time frame: 12 months
A healthy eating index score will be calculated at each time period from the FFQ. The scale ranges from 0-100 with 100 being the best possible score indicating healthy diet aligning with key dietary recommendations.
8 secondary outcomes
Rate of Participants Who Are Adherent to Self-Monitoring
Time frame: Baseline to 12 months
Dietary Self-Efficacy Scale (Diet-SE)
Time frame: 12 months
Self-Efficacy for Exercise Scale
Time frame: 12 months
Experiences of Discrimination Scale (EoD)
Time frame: 12 months
Patient Health Questionnaire (PHQ) for Adults, PHQ-9
Time frame: 12 months
Ideal Body Image
Time frame: 12 months
Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise
Time frame: 12 months
NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36070664Stephens J, Randolph J, Burke L, Miller C, Tan A, Buffington B, Melnyk B, Perkins A. A randomized controlled trial for reduction of risk factors for cardiovascular disease in young adults: Methods of the Aspire study. Contemp Clin Trials. 2022 Oct;121:106873. doi: 10.1016/j.cct.2022.106873. Epub 2022 Sep 5.
- Derived from this study: PubMed 34389927Leissa SM, Randolph JC, Stephens JD. Recruitment of Black Identifying Young Adults into Clinical Trials: a Report from the Field. J Urban Health. 2021 Oct;98(Suppl 2):155-159. doi: 10.1007/s11524-021-00569-4. Epub 2021 Aug 13. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone + Text Messaging with Health Coach in people with Obesity, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Baseline to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04412954, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.